Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDD) provides the current EU regulatory framework for In Vitro Diagnostic Medical Devices (IVDs). It establishes minimum requirements that are binding on all EU Member States and must be included in the respective national laws to ensure free trade of all In Vitro Diagnostic Medical Devices under its scope while supporting the highest level of protection of human health and safety. Following a public consultation in summer 2010, in which TÜV SÜD played an active role, and publication of its results in February 2011, a proposal for a harmonised European ”Regulation on In Vitro Diagnostic Medical Devices“ was drawn up by the commission and presented on September 26, 2012. The new regulation taken into consideration will introduce significant changes.
The old directive (IVDD) will be replaced by an EU regulation which will come into effect directly in all EU Member States without requiring transposition into national law. The new regulation will empower the Commission to take action. In the future, the Commission will be able to align requirements at short notice and change, say, the classification of individual devices. A central expert committee will be responsible for ensuring the harmonised interpretation of requirements. The future regulation also provides for closer monitoring of the Notified Bodies by the national authorities in cooperation with the EU. Existing designations will expire when the regulation enters into force. Designation under the new regulation requires re-assessment.
Clear rules for manufacturers of Medical Devices
In the future, the position of Notified Bodies vis-à-vis manufacturers will be strengthened, including the right to carry out unannounced factory inspections and physical or laboratory tests on samples. Compared to the IVDD, the new EU regulation establishes clearer requirements with respect to batch testing by the Notified Bodies. The conformity assessment procedure ”EC verification“ is no longer included.
The classification system for in vitro diagnostics has been changed significantly and is now based on classification rules instead of positive lists. In the future, IVDs will be divided into four classes of risk: A (lowest risk), B, C and D (highest risk). Even for class A devices, verification of the measuring function, sterilisation process or design of near-patient testing by a Notified Body is mandatory as far as applicable. This basically means that many devices are now in a higher risk class and will be subject to assessment or more in-depth assessment by a Notified Body in the future. In the case of new applications for conformity assessment of high-risk devices, the proposal introduces an obligation for Notified Bodies to notify an expert committee. The expert committee will have the power to request the Notified Body to submit a preliminary assessment.
Furthermore companion diagnostics will be included into the regulation and special requirements will be defined for near-patient (point of care) testing. Compared to the current regulation, the scope of applications will be extended on those produced and used within one health institution, if they are classified into the highest risk class (class D).
Improved transparency in every respect
Every device will be given an unique device identification (UDI). Serious incidents regarding a device and the corrective actions taken to address them will be collated in a central EU-wide electronic system in the future. Manufacturers will have to appoint a qualified person responsible for regulatory compliance and fulfill stricter requirements in the field of post market surveillance.
Obligations imposed on importers and distributors too have clearly increased. The same applies to clinical performance studies, which will be subject to stricter regulations. The Commission will further designate reference laboratories to define the state of the art and carry out tests within the scope of the assessment procedure.
A contemporary and stable regulatory framework
The proposal for a regulation on In Vitro Diagnostic Medical Devices was published alongside a proposal for the revision of the Directives on Medical Devices and Active Implantable Medical Devices. By harmonising the regulatory framework, the Commission aims at maintaining and improving the existing level of protection of human health and safety in the EU Member States. Some of the requirements of the IVDD lacked precision and leaded to some divergences in their interpretation and application. The classification system used so far proved too rigid to keep up with scientific and technological progress. Over the years changes and new risks that had not been addressed in the IVDD have evolved, including genetic tests and companion diagnostics. The revision also intends to overcome flaws in the old regulation, thus further improving patient safety. The objective is to create a robust, transparent, sustainable and, above all, ”fit-for-purpose“ regulatory framework.
New regulation expected to start in 2014
Within the scope of the EU legislative procedure, the proposal will now be submitted to the European Parliament for first reading. Passing of the new regulation following discussion and implementation of all changes resulting therefrom is expected in 2014. The regulation is to be applicable after a five-year transition period. Any certificates based on the IVDD issued by Notified Bodies before the regulation has entered into force will become invalid two years after the regulation‘s entry into force at the latest. Given this, manufacturers should keep their ears to the ground today. For them the costs and efforts involved in achieving regulatory compliance will increase significantly. Given this, additional resources must be established in a timely manner. Similarly, manufacturers must closely examine their QM systems and their processes, particularly those used to generate and document clinical data, and must review their available documentation for possible omissions. TÜV SÜD advises all manufacturers to strive early for an assessment carried out in accordance with the new regulation. In order to offer the required services at an early stage, TÜV SÜD is preparing intensively to meet the challenges of the new regulation and, as Notified Body, support manufacturers in taking all the necessary actions.
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